Real World Evidence Solutions Market worth $12.44 billion by 2031
The report "Real-world Evidence Solutions Market by Component [Datasets (Claims, Clinical, Pharmacy, Genomics), Application [Drug/Device Development (Cancer, Cardio, Neuro), Reimbursement], End User (Pharma, Medtech, Payers, Provider), Region- Global Forecast to 2031" is projected to reach USD 12.44 billion by 2031 from USD 6.22 billion in 2026, at a CAGR of 14.9% from 2026 to 2031.
Browse 190 market data Tables and 60 Figures spread through 265 Pages and in-depth TOC on "Real-world Evidence Solutions Market by Component [Datasets (Claims, Clinical, Pharmacy, Genomics), Application [Drug/Device Development (Cancer, Cardio, Neuro), Reimbursement], End User (Pharma, Medtech, Payers, Provider), Region- Global Forecast to 2031"
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The real-world evidence (RWE) solutions market is expanding as biopharma companies increasingly use real-world data to complement clinical-trial evidence and address evidence gaps across development, market access, and post-marketing activities. A recent example is Daiichi Sankyo’s use of supplemental RWE generated through Guardant Health’s InfinityAI platform, which contributed to Japan’s March 2026 approval of ENHERTU for previously treated patients with HER2-positive advanced or recurrent solid tumors. The RWE helped characterize treatment patterns and unmet need in a biomarker-defined population where conventional evidence generation can be challenging. These developments highlight the expanding role of RWE in rare diseases, precision medicine and regulatory submissions, boosting market growth.
By component, the data sets segment is growing at the fastest rate during the forecast period.
By component, the RWE solutions market is segmented into services and data sets. The data sets segment is expected to grow at the fastest rate in the RWE solutions market, driven by the rapid expansion of real-world data generated from electronic health records (EHRs), insurance claims, patient registries, pharmacy data, wearable devices, and other digital health technologies. The increasing digitization of healthcare is creating larger and more diverse data sets, enabling pharmaceutical and biotechnology companies to generate evidence across broader and more representative patient populations.
By application, the cardiovascular diseases segment accounted for the largest market share in 2025.
By application, the RWE solutions market is segmented into drug development & approvals, medical device development & approvals, post-market surveillance, market access and reimbursement decision-making, clinical & regulatory decision-making, and other applications. The drug development & approvals segment is bifurcated into oncology, cardiovascular diseases, neurology, immunology, rare diseases, and other therapeutic areas. Cardiovascular diseases held the largest share of the RWE solutions market, supported by the high prevalence of cardiovascular conditions and the need for long-term evidence on treatment effectiveness, safety, and patient outcomes. The growing availability of EHRs, claims data, patient registries, and patient-generated data is further expanding RWE use in cardiovascular care.
By end user, the medtech companies segment is growing at the fastest rate during the forecast period.
Based on end user, the RWE solutions market is segmented into pharmaceutical & biotechnological companies, medtech companies, healthcare payers, healthcare providers, and other end users. Medtech companies are expected to register the fastest growth in the RWE solutions market, as manufacturers increasingly use real-world data to demonstrate the safety, performance, and effectiveness of devices throughout their product lifecycles. The growing adoption of connected devices, AI-enabled medical technologies, remote monitoring solutions, and software as a medical device is generating larger volumes of device-generated and patient-generated data, creating greater opportunities for RWE generation.
By region, North America accounted for the largest share of the market in 2025.
By region, the RWE solutions market is segmented into five regions: North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. In 2025, North America accounted for the largest share of the market. This region’s dominance is attributed to the favorable regulatory environment and the increasing adoption of EHR. The US is a major contributor to this regional leadership, with extensive availability of claims, EHR, registry, and other real-world data sets. For example, IQVIA reported in 2025 that its US RWE network covered more than 318 million lives, including claims, EMR, patient-reported outcomes, and real-world wearable data. Additionally, an increase in the number of payers using RWE solution services is also expected to fuel the market growth. Moreover, the presence of key market players such as IQVIA Inc. (US), Optum Inc. (US), and Oracle (US) also contributes to market growth.
Key Players
The prominent players in the RWE solutions market are IQVIA Inc. (US), Merative (US), Optum Inc. (US), ICON Plc (Ireland), Syneos Health (US), Parexel International Corporation (US), Tata Consultancy Services (India), Oracle (US), Elevance Health (US), SAS Institute Inc. (US), Datavant (US), TriNetX, LLC (US), Trinity (US), Cognizant (US), Cegedim Health Data (France), Verantos (US), Medpace Holdings Inc. (US), Flatiron Health (US), Fortrea (US), and Medidata (US) (a subsidiary of Dassault Systèmes).
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